Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC

Study identifier:D3465C00001

ClinicalTrials.gov identifier:NCT04877691

EudraCT identifier:2020-004529-22

CTIS identifier:N/A

Recruiting

Official Title

A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus

Medical condition

Systemic Lupus Erythematosus

Phase

Phase 3

Healthy volunteers

No

Study drug

Medi-546, Placebo

Sex

All

Estimated Enrollment

360

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 08 Jun 2021
Estimated Primary Completion Date: 30 May 2025
Estimated Study Completion Date: 04 Sept 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

IQVIA

Inclusion and exclusion criteria